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EC number: 230-898-1 | CAS number: 7360-53-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 January 2010 to .............
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Aluminium triformate
- EC Number:
- 230-898-1
- EC Name:
- Aluminium triformate
- Cas Number:
- 7360-53-4
- Molecular formula:
- CH2O2.1/3Al
- IUPAC Name:
- aluminium triformate
- Details on test material:
- Size distribution: L10=5.9 µm, L50=13.4 µm, L90=46 µm.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 310 to 340 g (male) and 230 to 260 g (female)
- Fasting period before study: no
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids.
- Diet (e.g. ad libitum): Ssniff R/M-H maintenance diet for rats and mice (item V1534-300), ad libitum.
- Water (e.g. ad libitum): Tap water, acidified with HCl to a pH of >3, from an automatic watering system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 °C
- Humidity (%): 53.4 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12+12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 'nose-only' inhalation apparatus (TSE Systems GmbH, Bad Homburg, Germany; article no. 504101
- Exposure chamber volume: 19 L
- Method of holding animals in test chamber: Inhalation tubes
- Source and rate of air: Oil free, dried air from a central pressure pump, 1070 L/h
- System of generating particulates/aerosols: A dust generator acc. to Bundschuh (for the low and mid concentration) or acc. to Budiman (for the high concentration) , from TSE Systems GmbH, Bad Homburg, Germany
- Method of particle size determination: Cascade impactor (Berner-Impaktor Type LPI4/0,06/2 from Hauke KG, Gmunden, Austria with nine steps with cut-off- diameters from 0.06 µm to 16 µm.
- Temperature, humidity in air chamber: 20.6 to 21.2 °C, 12 to 38 % relative humidity
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric analysis
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 6.3 µm / 2.0 (low and mid concentration), 9.9 µm / 3.0 (high concentration)
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- 0.37, 1.29 and 2.51 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: during the acclimatisation period, before administration, 1, 3, 7 and 14 days p.a.
- Frequency of observations: 6 times on the day of exposure, once a day after.
- Necropsy of survivors performed: yes
- Histopathology of the lungs of the mid and high dosed group
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.51 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: 95 % CL is not calculatable.
- Mortality:
- All animals survived.
- Clinical signs:
- other: All animals of all groups were normal during the 14 days of the observation period.
- Body weight:
- The animals lost weight the first day after the exposure. This is caused by the restraining in the inhalation tube and not necessarily test substance related. The next days, most animals gained weight. There is no statistically significant linear correlation between the dust concentration and the body weight gain at any time after the exposure. There is however a clearly reduced body weight development in the high concentration group compared with the other two groups.
- Gross pathology:
- Nothing abnormal was seen in any of the animals.
- Other findings:
- - Histopathology: Perivascular oedema are considered to be fixation artefacts. Both alveolar and interstitial haemorrhages may be related to the test substance. They occurred randomly in both tested groups with a low degree of severity.
Any other information on results incl. tables
See Attachment.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The inhalation exposure of rats to "Aluminium triformate" at the maximal technically feasible concentration of 2.51 mg/L did not produce signs of toxicity. All animals survived and no well-defined adverse effects were observed during the 14-day observation period. Only the body weight gain in the high concentration group was reduced and histologically alveolar and interstitial haemorrhages were seen with a low degree of severity.
The differences to the results in the preliminary experiments, in which severe toxic signs were noted, may be explained as following:
• The animals in the preliminary experiments were smaller than in the main study, resulting in a higher breath volume per kg body weight.
• The dust concentration in the main experiment was slightly lower than in the preliminary experiment.
Therefore it is likely that the high concentration in this study is close to a concentration which would be toxic, but that a toxic dust concentration cannot be produced reproducible due to the properties of the test substance.
The LC50, per inhalation, four hours exposure, of "Aluminium triformate" for male and female rats is therefore greater than 2.51 mg per litre air which is the highest technically feasible dust concentration. - Executive summary:
The inhalation exposure of rats to"Aluminium triformate" at the maximal technically feasible concentration of 2.51 mg/L did not produce signs of toxicity. All animals survived and no well-defined adverse effects were observed during the 14-day observation period. Only the body weight gain in the high concentration group was reduced and histologically alveolar and interstitial haemorrhages were seen with a low degree of severity.
The differences to the results in the preliminary experiments, in which severe toxic signs were noted, may be explained as following:
· The animals in the preliminary experiments were smaller than in the main study, resulting in a higher breath volume per kg body weight.
· The dust concentration in the main experiment was slightly lower than in the preliminary experiment.
Therefore it is likely that the high concentration in this study is close to a concentration which would be toxic, but that a toxic dust concentration cannot be produced reproducibly due to the properties of the test substance.
The LC50, per inhalation, four hours exposure, of"Aluminium triformate" for male and female rats is therefore greater than 2.51 mg per litre air which is the highest technically feasible dust concentration.
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